MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HEADED SCREW 48 MM LENGTH; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00575001402 - femoral component - 63241623, 00595202110 - articular surface - 63738785, 00598002702 - tibial component - 63721655, 00579104100 - screw - 63777654, and 00597206529 - patella - 63572930.Report source: foreign: (b)(6).The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2021-00178, 0001822565-2021-02360, 0002648920-2021-00228, and 0001822565-2021-02362.

Event Description

It was reported that the patient underwent an initial right knee arthroplasty.Subsequently, the patient developed pain, stiffness, and limited range of motion that was unresolved with a manipulation under anesthesia.The patient underwent a revision approximately 3 years post implantation.Attempts have been made and no further information has been provided.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.This is an instrument that was used during surgery, not an implant.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.This is an instrument that was used during surgery, not an implant.The initial report was forwarded in error and should be voided.

• Brand Name: HEADED SCREW 48 MM LENGTH
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12356149
• MDR Text Key: 267752681
• Report Number: 0001822565-2021-02361
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00889024192805
• UDI-Public: (01)00889024192805(17)270930(10)63777648
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00579104100
• Device Lot Number: 63777648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female